药品不良反应报告数据规整的实践与思考

目的 我国药品不良反应报告数据增长迅速，但数据存在不规范现象，降低了药品不良反应监测与评价效率，影响了数据的有效利用。通过探讨数据规整方法 和应用，为提高我国药品不良反应报告质量提出建议和参考。方法 通过开展药品不良反应报告数据规整工作实践，对监测系统内的数据进行研究，归纳报告不规范现象、对其原因进行分析，探讨报告规范化、改善报告质量的方式方法 。结果 建立了标准数据库、规整规则数据库，对病例报告能够自动执行标准化工作。结论 数据规整是提升报告规范化的有效方法 ，在实际工作中具有重要作用。报告质量的提升是一项系统工程，需要各方共同努力。

Practice and Investigation on Data Normalization of Adverse Drug Reaction Reporting

Objective The reporting data of adverse drug reaction has been increasing more and more rapidly. Whereas, the existing nonstandard data decreased the efficiency of adverse drug reaction monitoring and evaluation, and influenced the effective use of the data. By discussing the methods and applications of data normalization, to provide reference and suggestion for improving the quality of reports. Methods On the basis of our real working practices in data normalization, the case reports from the monitoring system were studied, non standard reports were summarized and the reasons were analyzed, the methods of data normalization and reporting quality improvement were discussed. Results The standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of the new cases. Conclusion The data normalization is an effective method for improving the quality of the reports, it plays an important role in the actual work. Improving the quality of the reports is a systematic project , it needs the joint efforts of all the parties.